Numerous types of devices are enclosed in packaging of one kind or another. The packaging might range in its purpose and characteristics (e.g., circuit board wrapped in static resistant film, glass vase enveloped in bubble wrap, stereo receiver enclosed in a box). Each of these packaging systems has a desired goal with respect to the package contents. In some cases the packaging is oriented in a certain way so as to display the contents more openly. In other cases the packaging will be primarily to provide protection to the contents.
Some industries have very precise guidelines concerning the types of packaging that can be used to store certain types of goods. Sometimes these packaging systems are very costly to use as tooling cost and materials may require a significant outlay by the manufacturer or packaging producer. Further, changes in product configuration or packaging guidelines may mean that existing packaging may no longer meet the required specifications. The medical device industry requires sterile barrier packaging solutions for single-use Class II and Class III medical devices (or components). The two main types of sterile barrier packaging solutions are medical pouches (pouches) and custom thermoformed medical trays (trays).
FIG. 1 illustrates an example medical pouch 100. The pouch 100 includes two layers secured together with a seal 110 along a majority of the edges and an opening 120 for placing a medical device therein. The seal 110 may be such that any compromises therein are evident to a user so the device can be deposed of if the seal 110 was compromised. One of the two layers may be a clear material that enables a medical device contained therein to be seen. The other material may be a material that enables sterilization to occur (e.g., enables ethylene oxide to pass therethrough). After the medical device is inserted, the opening 120 in the pouch 100 may be sealed using bar sealing equipment and the pouch 100 may be sterilized using any number of known techniques. To remove the medical device from the pouch 100 a user simply pulls the layers of the pouch 100 apart.
The pouches 100 can be designed and produced at a relatively low cost and in a relatively short time frame. The operations required to seal the pouches 100 after the medical device has been inserted therein are relatively easy and low cost. Accordingly, the pouches 100 provide for a cost and operational effective means for providing sterile packaging of medical devices. Furthermore, the space required to store pouch inventory and equipment (bar sealing equipment) as well as the space required for operations (sealing) is relatively small.
However, the use of the pouches 100 is typically limited to certain types of medical devices, including devices and components that are lightweight by design and/or long catheter-type devices. The pouches may not be suitable for medical devices that, for example, have sharp edges that may puncture the pouch if the medical device shifts during transport or need a higher level of structural support.
FIG. 2 illustrates a custom thermoformed medical tray 200. The tray 200 provides a formed fit receptacle 210 within a main body 220 to hold a specific medical device 230. The main body 220 also provides structural support to protect the medical device 230 contained therein. The device 230 securely fits within the receptacle 210 and then a lid (not illustrated) is placed over the tray 200 and sealed thereon using sealing equipment. The lid may be sealed to the tray 200 along the edges 240 of the tray 200. To remove the device 230, the lid is removed from the tray 200 and the device is extracted from the receptacle 210. The design and production of the trays 200 may be relatively expensive and time consuming as it may require extensive prototyping, may require a relatively large amount of material (e.g., plastic) that needs to be tooled, and may require a user to implement a more costly batch production assembly method as changes in product mix may require different trays and tooling for continued packaging operations.
Furthermore, sealing the lids on the trays 200 may be relatively complex and time consuming (more complex and time consuming then the process for sealing pouches). For example, during the lid sealing procedure the lids may be prone to misplacement or having the device stuck in the seal areas. The additional complexity in the sealing process for the trays 200 may result in a relatively large amount of maintenance (more maintenance then for the pouches 100). Moreover, the space required to store the tray inventory and equipment (sealing equipment) as well as the space required for operations (sealing) may be relatively large (more space required then for pouches).
Accordingly, there is a tradeoff between the cost and logistical advantages of the pouches 100 and the structural advantages of the trays 200. Some devices require trays 200 such as devices that are heavier or have a higher profile. However, there are devices that utilize the trays simply because they cannot be used with the pouch 100 and there is no real alternative other that the tray 200.
FIG. 3 illustrates a block diagram of current medical device packaging spectrum 300. On one end of the spectrum 300 there are medical devices typically packaged within pouches 310. On the other end of the spectrum there are those devices that need to be packaged in the trays 330. In the middle of the spectrum are devices that utilize the trays but do not require the trays 320. Devices included in this part of the spectrum include cannula, trocar, catheter and many other devices.
Alternative packaging systems are needed for the devices within the middle of the spectrum 320. The alternative packaging systems should provide a sterile barrier solution with at least some of the cost and logistical advantages of the pouches 100 and at least some of the structural advantages of the trays 200.